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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ***UVC TRAY/3.5FR PU UMBILICAL VENOUS CATHETER

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COVIDIEN ***UVC TRAY/3.5FR PU UMBILICAL VENOUS CATHETER Back to Search Results
Model Number 8888160424
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Submit date: 2/20/17. An investigation is currently under way; upon completion the results will be forwarded.
 
Event Description
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a umbilical venous catheter. The customer reports noted by nurse to be leaking from small hole/crack near hub. A patient was involved but no harm was reported. The catheter was removed and replaced.
 
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Type of DeviceUMBILICAL VENOUS CATHETER
Manufacturer (Section D)
COVIDIEN
covidien manufacturing solutions sa
edificio 820 calle #2 zona france coyol
alajuela
CS
Manufacturer (Section G)
COVIDIEN
covidien manufacturing solutions sa
edificio 820 calle #2 zona france coyol
alajuela
CS
Manufacturer Contact
edward almeida
15 hampshire st.
mansfield, MA 02048
5084524151
MDR Report Key6342991
MDR Text Key68136573
Report Number3009211636-2017-00119
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 01/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160424
Device Catalogue Number8888160424
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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